Hydrocortisone - Generic Drug Details

What are the generic drug sources for hydrocortisone and what is the scope of freedom to operate?

Hydrocortisone is the generic ingredient in seventy-seven branded drugs marketed by Allergan Herbert, Crown Labs, Salix Pharms, Bayer Pharms, Monarch Pharms, Valeant Pharm Intl, Westwood Squibb, Pharm Assoc, C And M Pharma, Actavis Mid Atlantic, Alpharma Us Pharms, Altana, Ambix, Chartwell Molecular, Encube, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Naska, Padagis Us, Perrigo New York, Pharmaderm, Pharmafair, Rising, Stiefel, Syosset, Taro, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Valeant Intl, Bausch, Chartwell, Ani Pharms, Teva Pharms, Healthpoint, Eton, Pharmacia And Upjohn, Baker Norton, Legacy Pharma, Solvay, Beta Dermac, Bluline, Heran, Fougera Pharms, Mericon, Sun Pharma Canada, Dow Pharm, Pfizer Global, Cmp Pharma Inc, Dermik Labs, Torch, X Gen Pharms, Paddock Llc, Mission Pharma, Pfizer, Aurobindo Pharma Ltd, Barr, Elkins Sinn, Ferrante, Hibrow Hlthcare, Hikma Intl Pharms, Impax Labs, Impax Labs Inc, Inwood Labs, Nexgen Pharma Inc, Novitium Pharma, Panray, Parke Davis, Purepac Pharm, Roxane, Sandoz, Strides Pharma, Strides Pharma Intl, Watson Labs, Merck, Pfipharmecs, Viatris, Able, Cenci, Imperium, Bel Mar, Epic Pharma Llc, Fera Pharms, Colgate, Mylan Speciality Lp, Genus, Ferndale Labs, Glenmark Pharms Ltd, Taro Pharm Inds, Yamanouchi, Precision Dermat, Lupin Ltd, The J Molner, Abbott, Hospira, Abraxis Pharm, Apotex, Baxter Hlthcare, Cipla, Intl Medication, Cosette, Encube Ethicals, Padagis Israel, Sun Pharm Inds Inc, Amneal, Bausch And Lomb, Saptalis Pharms, Casper Pharma Llc, Sciegen Pharms, Schering, Forest Labs, Lederle, and Bioglan, and is included in two hundred and sixty-five NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydrocortisone has fifty-nine patent family members in twenty-five countries.

There are sixty-seven drug master file entries for hydrocortisone. Forty-one suppliers are listed for this compound.

Summary for hydrocortisone

International Patents:	59
US Patents:	5
Tradenames:	77
Applicants:	117
NDAs:	265
Drug Master File Entries:	67
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	482
Patent Applications:	7,898
Drug Prices:	Drug price trends for hydrocortisone
Drug Sales Revenues:	Drug sales revenues for hydrocortisone
What excipients (inactive ingredients) are in hydrocortisone?	hydrocortisone excipients list
DailyMed Link:	hydrocortisone at DailyMed

See drug prices for hydrocortisone

See drug sales revenues for hydrocortisone

Recent Clinical Trials for hydrocortisone

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Virginia	PHASE3
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE3
Assistance Publique - Hôpitaux de Paris	PHASE3

See all hydrocortisone clinical trials

Pharmacology for hydrocortisone

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for hydrocortisone

Anti-Inflammatory Agents

Anatomical Therapeutic Chemical (ATC) Classes for hydrocortisone

A01AC	Corticosteroids for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AA	Corticosteroids, weak (group I)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XA	Corticosteroids, weak, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for hydrocortisone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mission Pharma	TEXACORT	hydrocortisone	SOLUTION;TOPICAL	080425-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Solvay	DERMACORT	hydrocortisone	LOTION;TOPICAL	086462-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmaderm	HYDROCORTISONE	hydrocortisone	CREAM;TOPICAL	089413-001	Dec 16, 1986		DISCN	No	No

EU/EMA Drug Approvals for hydrocortisone

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch	Plenadren	hydrocortisone	EMEA/H/C/002185Treatment of adrenal insufficiency in adults.	Authorised	no	no	no	2011-11-03
Diurnal Europe B.V.	Alkindi	hydrocortisone	EMEA/H/C/004416Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).	Authorised	no	no	no	2018-02-09
Diurnal Europe B.V.	Efmody	hydrocortisone	EMEA/H/C/005105Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.	Authorised	no	no	no	2021-05-27

International Patents for hydrocortisone

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2664678	Композиция, содержащая гидрокортизон (COMPOSITION COMPRISING HYDROCORTISONE)
Spain	2782503
Lithuania	2780003

Supplementary Protection Certificates for hydrocortisone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0809498	SPC/GB10/012	United Kingdom		PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0809498	10C0038	France		PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026

Hydrocortisone: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Hydrocortisone, a corticosteroid, has maintained a significant market presence due to its anti-inflammatory and immunosuppressive properties. Its applications span a broad range of conditions, including dermatological issues, allergic reactions, and autoimmune diseases. The market is characterized by a mature generic landscape and ongoing innovation in drug delivery systems and formulations.

What are the primary therapeutic areas for hydrocortisone?

Hydrocortisone is utilized across multiple medical disciplines. Its anti-inflammatory action makes it a cornerstone treatment for various skin conditions.

• Dermatology: Used to treat eczema, psoriasis, dermatitis, and other inflammatory skin disorders. Topical formulations are widely prescribed.
• Allergy and Immunology: Manages severe allergic reactions, asthma, and anaphylaxis, often in injectable or oral forms.
• Rheumatology: Employed in the management of inflammatory arthritis and autoimmune diseases like lupus and rheumatoid arthritis.
• Endocrinology: Administered as hormone replacement therapy for adrenal insufficiency (Addison's disease).
• Ophthalmology: Treats inflammatory eye conditions.

What is the current market size and projected growth for hydrocortisone?

The global hydrocortisone market is substantial, driven by its established efficacy and accessibility, particularly in its generic forms. Precise market figures can vary between analytical reports, but general trends indicate steady demand.

• Estimated Market Size: Reports from market research firms place the global hydrocortisone market in the range of USD 500 million to USD 1 billion annually. For instance, Grand View Research estimated the global corticosteroid market, which includes hydrocortisone, to be valued at USD 8.9 billion in 2022, with a projected compound annual growth rate (CAGR) of 4.5% from 2023 to 2030 [1]. While this is for the broader corticosteroid class, hydrocortisone is a significant contributor.
• Growth Drivers: Key drivers include the increasing prevalence of inflammatory and autoimmune diseases, an aging global population, and growing awareness of treatment options. The demand for topical formulations, especially in emerging markets, also contributes to market expansion.
• Restraints: The market faces challenges from stringent regulatory approvals for new indications and the presence of lower-cost generic alternatives, which can limit price appreciation for established products.

Who are the key manufacturers and their market share?

The hydrocortisone market is fragmented, with a significant number of generic manufacturers alongside some proprietary product developers.

• Major Generic Players: Companies like Teva Pharmaceutical Industries, Mylan (now part of Viatris), Sun Pharmaceutical Industries, and Perrigo are prominent in the generic hydrocortisone segment. These companies leverage large-scale manufacturing capabilities to supply a cost-effective product.
• Specialty Formulators: Companies focusing on specific delivery systems or higher-potency formulations may also hold niche market positions.
• Market Share Dynamics: Due to the prevalence of generics, market share is often distributed across numerous entities. Market dominance is less about a single entity and more about the collective strength of generic suppliers. Exact market share data is proprietary and fluctuates, but a broad assessment indicates that the top 5-10 generic manufacturers likely account for a substantial portion of global volume.

What is the patent landscape for hydrocortisone?

As hydrocortisone itself is an old drug, the core compound patents expired decades ago. The patent landscape now focuses on:

• Formulation Patents: Innovations in drug delivery systems, such as sustained-release formulations, novel topical bases, or combination therapies, are patentable. These patents can extend market exclusivity for specific product versions.
• Manufacturing Process Patents: Improvements in synthesis routes or purification methods that offer cost savings, higher purity, or reduced environmental impact can be patented.
• New Indications: While challenging, securing patents for novel therapeutic uses of hydrocortisone, supported by robust clinical data, is possible.

Example Patent Trends:

• A search of patent databases reveals ongoing filings related to hydrocortisone topical compositions designed for enhanced skin penetration or reduced systemic absorption.
• Patents may also cover specific polymorphs or salt forms of hydrocortisone if they offer demonstrable advantages in stability or bioavailability.

The limited scope for fundamental patent protection on the active pharmaceutical ingredient (API) means that market exclusivity is primarily achieved through intellectual property on differentiated formulations and manufacturing advancements.

What is the regulatory status and approval pathway for hydrocortisone products?

Hydrocortisone products are subject to rigorous regulatory oversight by health authorities worldwide.

• United States (FDA):
  • New Drug Applications (NDAs): For novel formulations or new indications, a full NDA is required, involving extensive preclinical and clinical trials.
  • Abbreviated New Drug Applications (ANDAs): For generic versions, an ANDA is submitted, demonstrating bioequivalence to a reference listed drug.
  • Over-the-Counter (OTC) Status: Certain low-potency topical hydrocortisone formulations are available OTC.
• European Union (EMA):
  • Marketing Authorisation Application (MAA): Similar to an NDA, requiring comprehensive data.
  • Generics: Process relies on demonstrating similarity and bioequivalence.
• Other Jurisdictions: Regulatory pathways in countries like Japan (PMDA), Canada (Health Canada), and Australia (TGA) are comparable, requiring data to demonstrate safety, efficacy, and quality.

Key Regulatory Considerations:

• Good Manufacturing Practices (GMP): All manufacturing facilities must adhere to GMP standards.
• Post-Market Surveillance: Ongoing monitoring for adverse events is mandatory.
• Labeling Requirements: Prescribing information must be accurate and up-to-date.

What are the pricing strategies and reimbursement policies?

Pricing and reimbursement for hydrocortisone products are highly dependent on their formulation, indication, and market status (branded vs. generic).

• Generic Hydrocortisone: Prices are highly competitive and driven by supply and demand. Bulk purchasing agreements with hospitals and pharmacy benefit managers (PBMs) are common. Prices are generally low, reflecting the mature nature of the market.
• Branded or Differentiated Formulations: Products with novel delivery systems or unique clinical advantages may command premium pricing. However, payers often scrutinize the incremental benefit to justify higher costs, especially against established generics.
• Reimbursement:
  • Insurance Coverage: Most prescription hydrocortisone products are covered by commercial and government health insurance plans (e.g., Medicare, Medicaid in the US).
  • Formulary Placement: PBMs and insurance companies determine formulary placement, influencing accessibility and out-of-pocket costs for patients. Generic hydrocortisone typically enjoys broad formulary inclusion.
  • OTC Products: Not typically covered by insurance, with patients paying out-of-pocket.

Pricing Trends: The trend for generic hydrocortisone is towards price erosion due to intense competition. Price increases are more feasible for patented, innovative formulations that demonstrate a clear clinical advantage and meet payer value thresholds.

What are the future market opportunities and challenges?

The hydrocortisone market, while mature, presents ongoing opportunities and challenges.

Market Opportunities:

• Advanced Drug Delivery Systems: Development of hydrocortisone formulations with improved efficacy, reduced side effects, or enhanced patient compliance (e.g., once-daily topical applications, inhalable formulations for respiratory conditions).
• Combination Therapies: Formulating hydrocortisone with other active ingredients to target multiple pathways of inflammation or disease.
• Emerging Markets: Growing healthcare infrastructure and increasing access to treatments in developing economies present opportunities for both generic and specialized hydrocortisone products.
• Orphan Indications: Investigating hydrocortisone for rare diseases where existing treatment options are limited could lead to market exclusivity and premium pricing.
• Biologics Biosimilars: While not directly hydrocortisone, the rise of biologics for inflammatory diseases creates a market for cost-effective corticosteroid alternatives like hydrocortisone for initial treatment or steroid-sparing strategies.

Market Challenges:

• Competition: Intense competition from numerous generic manufacturers keeps prices low and limits profit margins.
• Regulatory Hurdles: Obtaining approval for new indications or formulations requires significant investment in clinical trials and can be time-consuming.
• Physician and Patient Preferences: Shifting treatment paradigms towards biologics for severe inflammatory conditions could reduce the reliance on corticosteroids like hydrocortisone for some patient populations.
• Side Effect Profile: Long-term use of systemic corticosteroids can lead to significant side effects, prompting a search for alternatives.
• Antimicrobial Resistance: In some topical applications, hydrocortisone is combined with antimicrobials. The rise of antimicrobial resistance presents a challenge for these combination products.

Key Takeaways

Hydrocortisone remains a vital therapeutic agent with stable demand driven by its broad applicability in inflammatory and autoimmune conditions. The market is largely dominated by generic manufacturers, leading to price competition. Future growth potential lies in innovative drug delivery systems, combination therapies, and expansion into emerging markets. Regulatory pathways for new formulations and indications are complex and require substantial investment.

Frequently Asked Questions

1. What is the primary difference between branded and generic hydrocortisone? Branded hydrocortisone typically refers to a specific manufacturer's product, often with proprietary formulation or delivery technology. Generic hydrocortisone is chemically equivalent to the branded product but is sold at a lower price after patent expiry.
2. Are there any emerging new uses for hydrocortisone currently under investigation? Research continues into optimizing hydrocortisone delivery and exploring its role in specific inflammatory pathways for conditions where current treatments are insufficient, but significant new indications are rare given its long history.
3. How does the increasing use of biologics impact the hydrocortisone market? The rise of biologics for severe inflammatory diseases may reduce the reliance on systemic corticosteroids like hydrocortisone in some cases. However, hydrocortisone often remains a first-line or adjunctive therapy and is crucial for managing milder conditions or as a cost-effective option.
4. What are the key factors influencing the pricing of hydrocortisone products? Pricing is primarily influenced by competition among generic manufacturers, manufacturing costs, regulatory compliance, and, for differentiated products, the extent of patent protection and demonstrated clinical value.
5. Can hydrocortisone be effectively used in combination with other drugs? Yes, hydrocortisone is frequently formulated in combination with other active pharmaceutical ingredients, such as antibiotics, antifungals, or other anti-inflammatory agents, to enhance efficacy in treating complex conditions.

Citations

[1] Grand View Research. (2023). Corticosteroid Market Size, Share & Trends Analysis Report By Type (Glucocorticoids, Mineralocorticoids), By Route Of Administration (Oral, Topical, Injectable, Nasal, Ophthalmic), By Application (Asthma, COPD, Dermatitis, Arthritis, Allergies, Others), By End-use, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/corticosteroid-market